Thank you for this great document,
@Jonathan Edwards
I have written my comment in portions and come late to this discussion, not having read all comments. Thus, anticipated apologies for a likely disjointed and maybe redundant reply.
In addition to the points highlighted by earlier comments, Jonathan Edward's piece in my opinion encloses useful points to be pursued beyond addressing national authorities, i.e. could be helpful addressing those institutionalized forms of medical science traditions that continue to back the
Dysfunctional Beliefs and Behaviours model* of ME/CFS on a broader level -- most importantly maybe Cochrane.
I am a bit worried about how to handle the general question about trial methodology in psychological medicine, though.
With regard to the current BPS approach to ME and "functional/ somatoform disorders", I fully agree with this:
The standard of assessment of evidence in psychological medicine appears to be well below other specialities.
Yet I see two possible conclusions:
1) Most psychiatrists and psychologists are aware of the problem, and might integrate this awareness in their medical practice, i.e. be very cautious to apply treatments labeled in trials as "moderate" effective, whereas "high evidence" wouldn't even exist as a label for treatments. (Actually does not exist in the NICE guideleines I skimmed, also does not exist in the Cochrane review of GET trials. Of course these sources are not sufficient to draw any conclusions).
Malpractice then would be only the fault of a minority of psychiatrists and psychologists neglecting an otherwise acknowledged methodology problem and propagating unsupported claims of "moderate effects" or even "high quality" evidence. Since the evaluation of ME trials is allocated to the Cochrane "mental health group" (and I don't think there is a multidisciplinary assessment in the Cochrane "mental health" group), ME trials are evaluated solely by reviewers who are used to see their low standards as regular. Physicians of other disciplines however rely on the Cochrane evaluation with other standards in mind.
or 2) -- there is, in general...
a serious weakness in the quality of both science and peer review in psychological medicine.
On the one hand it's hard to imagine that there might be a general weakness that has not been addressed before within the disciplines of psychology and psychiatry. Is there really no past or ongoing debate within these disciplines regarding both the participants' and the investigators' bias inherent to the methodology of treatment assessment, necessitating objective measures when blinding is not possible?
Depending on how this question is to be answered, the following sentence could be over-generalizing:
Peer review in psychological medicine appears to be peculiarly unable to appreciate the problem of unwitting psychological bias that is recognised even in basic science laboratories.
On the other hand, I know from my (non-medical and non-psychological) field of expertise how persistent elephants in a room can be, and how scholars hand on blind spots until these blind spots become an essential part of professional knowledge.
I see the risk of exposing an affront instead of an elephant, though.
Thus I would like to know what the more sophisticated psychologists and psychiatrists think about the challenges of common psychological / psychiatric trial practice due to both investigators' and participants' bias. It would be great to know what e.g. the psychiatrists and psychologists who signed the open letter (by
@dave30th and Vincent Racaniello) to the Lancet think: Do they see a general weakness in methodology which within their field of expertise has not been properly addressed yet? Or is it rather a generally acknowledged weakness which only some investigators and reviewers within their field, but more often medical and health care professionals external to their field, fail to address and handle properly?
Any way, I think with highlighting the starting point that
ME remains a very difficult problem
,
there might be an elegant way to address the challenges in trial methodology of treatments that cannot be blinded, free from any flavor of denigrating a whole discipline.
In an other thread,
@Sasha put it in plain language:
It seems to me that ME is at the centre of a perfect storm of medical crap - the rush to assume that poorly understood illnesses are 'all in the mind', the low quality of psychiatric trials, the irresponsibility of institutions when faced with bad trials, the absence of anyone to take charge of dealing with 'new' diseases, and this - no system for dealing with harms from psychosocial interventions.
Perhaps gift-wrapping ME as one of the most urgent multidisciplinary riddles that needs new sophisticated tools to get solved, while the solving process will provide findings and new insights into the understanding of other medical challenges, and at the same time will lay open blind spots in diverse areas of medical research, practice, and healthcare, could attract more top level scientists to investigate in high quality research on ME?
*
@Hutan 's term:
https://www.s4me.info/posts/84532/